Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 28, 2023; 29(8): 1330-1343
Published online Feb 28, 2023. doi: 10.3748/wjg.v29.i8.1330
Intestinal complications in Brazilian patients with ulcerative colitis treated with conventional therapy between 2011 and 2020
Adalberta Lima Martins, Rodrigo Galhardi Gasparini, Ligia Yukie Sassaki, Rogerio Saad-Hossne, Alessandra Mileni Versut Ritter, Tania Biatti Barreto, Taciana Marcolino, Claudia Yang Santos
Adalberta Lima Martins, Espirito Santo Health Office, State Office for Pharmaceutical Assistance, Espirito Santos 29056-030, Brazil
Rodrigo Galhardi Gasparini, Department of Gastroenterology, Specialized Medical Center, Marília 17502-020, Brazil
Ligia Yukie Sassaki, Rogerio Saad-Hossne, Department of Gastroenterology, Sao Paulo State University, Medical School, Botucatu 18618-687, Brazil
Alessandra Mileni Versut Ritter, Real World Evidence, IQVIA Brazil, Sao Paulo 04719-002, Brazil
Tania Biatti Barreto, Taciana Marcolino, Claudia Yang Santos, Department of Gastroenterology, Takeda Pharmaceuticals Brazil, Sao Paulo 04794-000, Brazil
Author contributions: Martins AL, Galhardi Gasparini R, Sassaki LY, Saad-Hossne R, Barreto TB, Marcolino T and Yang Santos C participated in designed, interpretation of the data and revised the article critically for important intellectual content; Ritter AMV participated in the acquisition, analysis and draft the initial manuscript.
Institutional review board statement: In alignment with Brazilian ethical resolution number 510, 2016, ethical approval was not necessary since this is a secondary study using anonymized data.
Conflict-of-interest statement: Martins AL served on the advisory board of Takeda, AbbVie, Janssen, Pfizer and Amgen and is a speaker for Amgen and Janssen. Galhardi Gasparini R is a speaker for Janssen, Takeda and AbbVie. Sassaki LY is a speaker for Janssen and Takeda and participated in the advisory boards of Takeda and AbbVie. Saad-Hossne R is a speaker and on the advisory boards for AbbVie, Takeda, Janssen, Pfizer, Fresenius and Amgen, as well as a speaker for Novartis. AMVR is an employee of IQVIA Brazil. Marcolino T, Barreto TB and Yang Santos C are employees of Takeda Pharmaceutical Brazil.
Data sharing statement: No additional data are available.
STROBE statement: The authors have read the STROBE statement, and the manuscript was prepared and revised according to the STROBE statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Claudia Yang Santos, BPharm, MSc, PhD, Research Scientist, Department of Gastroenterology, Takeda Pharmaceuticals Brazil, Av. das Nações Unidas, 14401 Torre Jequitiba, 11 Andar, Sao Paulo 04794-000, Brazil. clausantos2910@gmail.com
Received: September 30, 2022
Peer-review started: September 30, 2022
First decision: December 1, 2022
Revised: December 9, 2022
Accepted: February 14, 2023
Article in press: February 14, 2023
Published online: February 28, 2023
Processing time: 150 Days and 23.9 Hours
ARTICLE HIGHLIGHTS
Research background

This was an observational, descriptive, and retrospective study from 2011 to 2020 from the Department of Informatics of the Brazilian Healthcare System database.

Research motivation

To understand the real world situation of patients with ulcerative colitis (UC) in the public healthcare system.

Research objectives

Describe the intestinal complications (IC) of patients with UC who started conventional therapies.

Research methods

Patients ≥ 18 years of age who had at least one claim related to UC International Statistical Classification of Diseases and Related Health Problems (ICD-10) code and at least 2 claims for conventional therapies were included. IC was defined as at least one claim of: UC-related hospitalization, procedures code for rectum or intestinal surgeries, and/or associated disease defined by ICD-10 codes.

Research results

In total, 41229 UC patients were included. Overall IR of IC was 3.2 cases per 100 PY. Among the IC claims, 54% were related to associated diseases, 20% to procedures and 26% to hospitalizations. The overall annual incidence of IC was 2.9%, 2.6% and 2.5% in the first, second and third year after the first claim for therapy (index date), respectively. Over the first 3 years, the annual IR of UC-related hospitalizations ranged from 0.8% to 1.1%; associated diseases from 0.9% to 1.2%.

Research conclusions

Study shows that UC patients under conventional therapy seem to present progression of disease developing some IC, which may have a negative impact on patients and the burden on the health system.

Research perspectives

Biologics were implemented in the public healthcare system after the study period, it would be interesting to verify the IC impact of this implementation in patients with UC.